乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.041746121742021740581742261746361743470.15
215.161749241748041748640.05
单位质量响应值RSD%判断
11592.2211534.560.36数据可信
供试品溶液-1234026批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min135035-3503518.08517.512.9518.0817.512.94
232859-3285916.96116.96
333634-3363417.36117.36
433539-3353917.31217.31
535273-3527318.20718.21
633181-3318117.12717.13
60min157123-5712329.48629.062.2229.5229.092.22
255208-5520828.49728.53
355705-5570528.75428.78
455535-5553528.66628.70
558460-5846030.17630.21
655781-5578128.79328.82
120min190060-9006046.48846.142.2546.5746.222.25
288133-8813345.49345.57
389713-8971346.30846.39
487164-8716444.99345.07
592869-9286947.93748.02
688440-8844045.65145.73
240min1138917-13891771.70770.971.5471.8671.121.55
2137070-13707070.75370.90
3138370-13837071.42471.58
4135287-13528769.83369.98
5140349-14034972.44672.61
6134974-13497469.67169.82
360min1169259-16925987.36986.131.3587.6586.411.35
2166835-16683586.11886.39
3167797-16779786.61486.89
4163410-16341084.35084.62
5168776-16877687.11987.40
6165106-16510685.22585.49
480min1184830-18483095.40694.601.1495.8395.021.15
2182745-18274594.33094.74
3184815-18481595.39995.82
4180188-18018893.01093.42
5185413-18541395.70796.13
6181650-18165093.76594.18
600min1194090-194090100.18699.041.15100.7799.621.15
2191277-19127798.73499.30
3192320-19232099.27299.85
4188611-18861197.35897.92
5194398-194398100.345100.93
6190580-19058098.37498.94
720min1197203-197203101.793100.541.21102.54101.281.21
2194337-194337100.314101.05
3194268-194268100.278101.02
4191349-19134998.77199.50
5197713-197713102.056102.81
6193782-193782100.027100.76
960min1198137-198137102.275101.061.10103.19101.961.10
2194291-194291100.290101.19
3196634-196634101.499102.41
4192588-19258899.411100.30
5197770-197770102.086103.01
6195240-195240100.780101.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1200838-200838103.669101.861.37104.76102.931.37
2195556-195556100.943102.01
3197966-197966102.187103.27
4193331-19333199.794100.85
5199379-199379102.916104.01
6196885-196885101.629102.69
1440min1198918-198918102.678101.131.24103.94102.381.24
2194254-194254100.271101.51
3195837-195837101.088102.34
4192392-19239299.310100.53
5198186-198186102.300103.57
6195949-195949101.146102.38
极限1199301-199301102.876100.941.33104.31102.351.33
2194177-194177100.231101.64
3195603-195603100.967102.38
4191990-19199099.102100.49
5197550-197550101.972103.41
6194667-194667100.484101.89
乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.041745001742831742401737621744011742370.17
215.161743201746521744860.14
单位质量响应值RSD%判断
11584.9111509.630.47数据可信
供试品溶液-1234026批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min132490-3249016.79417.303.7516.7917.303.76
235284-3528418.23918.24
333287-3328717.20617.21
434719-3471917.94617.95
532685-3268516.89516.90
632294-3229416.69316.69
60min154219-5421928.02628.772.8128.0528.802.82
257684-5768429.81729.85
355628-5562828.75428.78
457386-5738629.66329.69
554926-5492628.39228.42
654069-5406927.94927.98
120min186866-8686644.90245.452.1444.9845.522.14
290335-9033546.69546.77
387392-8739245.17445.25
490141-9014146.59546.67
587033-8703344.98845.06
685761-8576144.33044.40
240min1134335-13433569.43970.051.4769.5970.201.47
2138057-13805771.36371.52
3134545-13454569.54769.70
4138030-13803071.34971.51
5134392-13439269.46869.62
6133728-13372869.12569.27
360min1164055-16405584.80185.051.0485.0785.321.04
2166683-16668386.16086.44
3164621-16462185.09485.36
4166359-16635985.99286.27
5162784-16278484.14484.41
6162750-16275084.12784.39
480min1180558-18055893.33293.951.0093.7494.361.00
2183468-18346894.83695.26
3182627-18262794.40194.81
4183913-18391395.06695.49
5179811-17981192.94693.35
6180116-18011693.10393.51
600min1187585-18758596.96498.301.0797.5398.871.07
2191878-19187899.18399.76
3192502-19250299.506100.07
4191393-19139398.93299.51
5189255-18925597.82798.39
6188431-18843197.40197.96
720min1191319-19131998.89499.971.0799.62100.701.07
2195543-195543101.078101.82
3195807-195807101.214101.95
4194238-194238100.403101.15
5192112-19211299.304100.03
6191392-19139298.93299.65
960min1193295-19329599.916100.520.97100.80101.420.96
2195229-195229100.915101.83
3197467-197467102.072102.97
4195008-195008100.801101.71
5193625-193625100.086100.98
6192128-19212899.312100.20
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193941-193941100.249101.481.19101.30102.541.19
2197774-197774102.231103.31
3200109-200109103.438104.51
4196460-196460101.552102.63
5195359-195359100.982102.04
6194282-194282100.426101.48
1440min1191415-19141598.944100.181.14100.17101.421.14
2195339-195339100.972102.22
3196887-196887101.772103.02
4194862-194862100.726101.97
5192593-19259399.553100.78
6191773-19177399.129100.35
极限1191131-19113198.797100.051.18100.18101.451.18
2194599-194599100.590102.01
3197293-197293101.982103.40
4194109-194109100.336101.75
5192430-19243099.468100.86
6191713-19171399.098100.48
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